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A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus Clinical research trials and A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus. A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus clinical trial. Human subjects often get the best healthcare possible for their A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus  A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
For Condition: Cytomegalovirus Infections,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts <= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Topical or ophthalmic nucleoside analogs. Patients must have: - Confirmation of HIV infection. - Documented CMV infection. - No past or present CMV disease (e.g., retinitis, colitis, esophagitis). - Adequate visualization of the retina of both eyes by ophthalmologist. - CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication). - Inability to comply with protocol. Concurrent Medication: Excluded: - The following nucleoside analogs: - IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine. - FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC. - Imipenem-cilastatin (Primaxin). Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir. Prior Medication: Excluded within the past 60 days: Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.
Total Enrollment: 700
Location and Contact Information:
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
Chicago, Illinois, 60612
United States
Davies Med Ctr / c/o HIV Institute
San Francisco, California, 94114
United States
Kraus - Beer Med Group
Los Angeles, California, 90028
United States
UCSD
San Diego, California, 92103
United States
Kaplan Cancer Ctr / New York Univ Med Ctr
New York City, New York, 10016
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Beth Israel Hosp
Boston, Massachusetts, 02215
United States
Infectious Diseases Association of Houston
Houston, Texas, 77030
United States
St Lukes - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Harbor - UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, 15261
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Oak Lawn Physicians Group
Dallas, Texas, 75219
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Cornell Univ Med College / New York Hosp
New York City, New York, 10021
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Mount Zion Med Ctr
San Francisco, California, 94115
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Community Research Initiative
Coral Gables, Florida, 33146
United States
Additional Information:
Study ID Numbers: 059D; ICM 1654
Study Start Date:
Record last reviewed: November 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002095
Other Cytomegalovirus Infections Studies:
1. Follow-up assessment of subjects who received ganciclovir for CMV infections
2. A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
3. Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women with Chronic Infections
4. Prospective Study of HIV Infection in Hemophiliacs
5. Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study
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A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
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